JP2021518594A - Ostomy system, attached devices, and related methods - Google Patents

Abstract

The method and ancillary devices for the ostomy system, including the monitor device and the ostomy brace, which includes the base plate, are disclosed. Attached devices include a memory, processor, and an interface that is coupled to the processor and configured to communicate with the monitor device, and the interface includes a display to retrieve monitor data from the monitor device coupled to the ostomy appliance. The monitor data includes the sensor data and one or more of the ostomy data obtained from the electrodes of the base plate, and the parameter data based on the ostomy data obtained from the electrodes of the base plate, and the sensor data is 1 in the monitor device. Acquired from one or more sensors, the processor determines the operating state of the base plate based on the sensor data and parameter data based on one or more of the ostomy data and the ostomy data, and shows the operating state of the base plate on the display. It is configured to display a first user interface that includes a first user interface object.

Description

The present disclosure relates to ostomy systems and their devices. The ostomy system includes ostomy equipment and monitor devices. In particular, the present disclosure relates to ancillary devices and related methods for monitoring and communicating the operating state of the base plate based on the sensor data of the monitor device.

The accompanying drawings are included to provide a better understanding of the embodiments and are incorporated herein by reference. The drawings serve to show embodiments and explain the principles of the embodiments as well as the description. Many of the other embodiments and the intended benefits of the embodiments will be readily recognized as they are better understood by reference to the detailed description below. The elements of the drawing are not necessarily drawn to each other at a constant scale. Similar reference numerals indicate corresponding similar parts.

FIG. 1 shows an exemplary ostomy system. FIG. 2 shows an exemplary monitor device for an ostomy system. FIG. 3 is an exploded view of the base plate of the ostomy orthosis. FIG. 4 is an exploded view of an exemplary electrode assembly. FIG. 5 is a proximal view of the base plate. FIG. 6 is a distal view of an exemplary electrode configuration. FIG. 7 is a distal view of an exemplary masking element. FIG. 8 is a distal view of an exemplary first adhesive layer. FIG. 9 is a proximal view of the first adhesive layer of FIG. FIG. 10 is a distal view of the base plate including the monitor interface. FIG. 11 shows an exemplary accessory device according to the present disclosure. FIG. 12 shows an exemplary accessory device according to the present disclosure. FIG. 13 shows an exemplary accessory device according to the present disclosure. FIG. 14 shows an exemplary method according to the present disclosure. FIG. 15A is an exemplary graph of parameter data as a function of time for different predetermined temperatures. FIG. 15B is an exemplary graph of parameter data as a function of time for different predetermined temperatures.

Various exemplary embodiments and details, where relevant, will be described below with reference to the figures. Note that figures may or may not be drawn to a certain scale, and elements of similar structure or function are represented by similar reference numerals throughout the figure. It should also be noted that the figures are for the purpose of facilitating the description of embodiments only. The figures are not intended as an exhaustive description of the invention or as a limitation to the scope of the invention. In addition, the embodiments shown do not have to have all of the embodiments or advantages shown. The embodiments or advantages described in conjunction with a particular embodiment are not necessarily limited to embodiments and are to be implemented in any other embodiment even if not so indicated or expressly described. Is possible.

Throughout this disclosure, the terms "stoma" and "ostomy" are used to refer to surgically constructed openings that bypass the human intestinal or urinary system. These terms are used synonymously and are not intended to make a distinction. The same applies to any term or phrase derived from these terms, such as "stoma", "plurality of ostomy", etc. In addition, solid waste and liquid waste generated from a stoma can synonymously refer to both the stoma "emission", "waste" and "fluid". Subjects who have undergone ostomy surgery may also be referred to as "ostomists" or "ostomates" -and "patients" or "users." However, in some cases, "user" may be associated with or refer to a healthcare professional (HCP) such as a surgeon or ostomy care nurse. In those cases, the "user" is either explicitly stated not to be the "patient" itself, or implicit from the context.

In the following, whenever referring to the proximal side or proximal surface of a layer, element, device or part of a device, the reference is to the skin-facing side or surface when the user wears the ostomy brace / monitor device. It is a reference. Similarly, whenever a layer, element, device or portion of a device is pointed to the distal or distal surface, the reference faces the opposite of the skin when the user is wearing an ostomy orthosis / monitor device. A reference to the side or surface. In other words, when the orthosis is worn by the user, the proximal or proximal surface is the side or surface closest to the user, and the distal side is the opposite or opposite surface-from the user in use. The farthest side or surface.

Axial direction is defined as the direction of the stoma when the user is wearing the brace. Therefore, the axial direction is generally orthogonal to the user's skin or abdominal surface.

The radial direction is defined as being orthogonal to the axial direction. Depending on the text, the terms "internal" and "external" may be used. These modifiers are generally recognized in the radial direction such that a reference to an "outer" element is farther away from the central part of the ostomy brace than the element referred to as "inner". It should be. In addition, "innermost" should be interpreted as the part of the component that forms the center of the component and / or the part adjacent to the center of the component. Similarly, "outermost" should be construed as a part of a component that forms the outer edge or outer contour of the component and / or a part adjacent to that outer edge or outer contour.

The use of the term "substantially" as a modifier to a particular feature or effect in the present disclosure indicates that any deviations are usually within the tolerances expected by those skilled in the art. It is intended to mean simply.

The use of the term "generally" as a modifier to a particular feature or effect in the present disclosure, in the case of structural features, indicates that most or most of such features are problematic and functional. In the case of a feature or effect, it is intended to simply mean that most of the results associated with that property provide that effect, but exceptional results do not.

The present disclosure relates to devices of an ostomy system such as an ostomy system and an ostomy brace, a base plate of the ostomy brace, a monitor device, and optionally one or more accessory devices. In addition, methods related to the ostomy system and devices of the ostomy system are disclosed. The ancillary device (also referred to as an external device) can be a mobile phone or other handheld device. The accessory device can be, for example, a wearable personal electronic device, such as a wristwatch or other wrist-worn electronic device. The attached device can be a docking station. The docking station may be configured to electrically and / or mechanically couple the monitor device to the docking station. The docking station may be configured to charge the monitor device and / or transfer data between the monitor device and the docking station. The ostomy system may include a server device. The server device may be operated and / or controlled by the ostomy equipment manufacturer and / or service center.

The ostomy system includes an ostomy brace and a monitor device, the ostomy brace including a base plate is disclosed, and the monitor device is the monitor device described herein.

An ostomy system comprising a monitoring device and an ostomy device including a base plate is disclosed, wherein the base plate has a first adhesive layer having a proximal side configured to attach the base plate to the user's skin surface. The adhesive layer of 1 has a ostomy opening having a center point, and the monitor device includes a processor and a sensor unit including a first sensor having a first sensor surface housed in the monitor device housing. Including, the monitor device housing has a sensor opening on the proximal surface of the monitor device, which forms at least a portion of the sensor path from the periphery of the proximal surface to the first sensor surface.

Also disclosed is a monitor device for ostomy equipment of an ostomy system, the monitor device comprising a processor and a sensor unit including a first sensor having a first sensor surface housed within the monitor device housing. The monitor device housing has a sensor opening in the proximal plane of the monitor device, the proximal plane being configured to face the user's skin during use, and the sensor opening around the proximal plane. It forms at least a part of the sensor path from to the first sensor surface.

The present disclosure may facilitate reliable monitoring of an ostomy system and its devices, such as an ostomy brace, a base plate for the ostomy brace, a monitor device, and optionally, alone or collectively, the ostomy brace. Provide one or more accessory devices.

The ostomy brace includes a base plate and an ostomy pouch (also called an ostomy bag). The ostomy orthosis can be an artificial anal orthosis, an ileostomy orthosis or an artificial bladder orthosis. The ostomy brace can be a two-part ostomy brace, i.e., the base plate and ostomy pouch can be releasably coupled using, for example, a mechanical and / or adhesive bond, thereby, for example, multiple ostomy pouches. Make it available (replaceable) with one base plate. In addition, the two-part ostomy orthosis can facilitate the accurate application of the base plate to the skin, for example, by facilitating an improvement in user vision in the ostomy area. The ostomy brace can be a single ostomy brace, i.e. the base plate and the ostomy pouch can be attached fixed to each other. The base plate is configured to bind to the skin around the stoma, such as the user's stoma and / or the surrounding skin area.

A base plate for an ostomy appliance is disclosed, which is a first adhesive layer having a proximal side configured to attach the base plate to the user's skin surface and having a stoma opening having a center point. It includes one adhesive layer, a ground electrode, a first electrode, and a plurality of electrodes including optionally a second electrode, the ground electrode includes a ground connection, and the first electrode is a first electrode. Includes a connection, the second electrode comprises a second connection, and the ground electrode forms a ground for the first and / or second electrode.

The base plate contains a first adhesive layer. During use, the first adhesive layer adheres to the user's skin (the area around the stoma) and / or additional seals such as sealing paste, sealing tape, and / or sealing ring. Therefore, the first adhesive layer can be configured to attach the base plate to the user's skin surface. The first adhesive layer has a stoma opening with a center point, or is made to form at least a stoma opening with a center point. Identifying the erosion / expansion characteristics or properties of the first adhesive layer by means of a base plate having three electrodes at which the detector contacts the first adhesive layer, and / or erosion and / or the first adhesive layer. The degree of swelling can be specified.

It is an advantage of the present disclosure that an optimal or improved use of the ostomy brace is provided. In particular, the present disclosure allows base plate replacement too early (leading to increased desquamation from the skin and increased risk of skin damage, leading to wasted costs and / or increased material) or too late (adhesion failure). , Leakage, and / or lead to skin damage from excess emissions). Therefore, the user or healthcare professional can monitor and plan the use of the ostomy brace.

In addition, determining the operating state of the base plate and the classification of the operating state is useful to help reduce the risk of the user experiencing, for example, a leak from the ostomy brace between the skin and the base plate. In addition, determining the operating state of the base plate and the classification of the operating state is useful in helping to reduce the risk of skin damage to the user. In particular, the determination of operating conditions according to the present disclosure may help provide a clear distinction or distinction between adhesion failure and leakage of emissions harmful to the skin and ostomate sweating.

The present disclosure provides a simple, efficient, and easy-to-use ostomy orthosis system that is highly comfortable for the user.

The first adhesive layer can be made of the first composition. The first composition may comprise one or more polyisobutenes and / or styrene-isoprene-styrene. The first composition may include one or more hydrophilic colloids.

The first composition may be a pressure sensitive adhesive composition suitable for medical purposes, comprising an elastic elastomer base and one or more water-soluble or water-expandable hydrophilic colloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrophilic colloids, or any combination thereof. The combination of the adhesiveness of polybutene and the absorbency of hydrophilic colloids makes the first composition suitable for use in ostomy orthoses. The styrene copolymer can be, for example, a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are utilized. The amount of styrene block copolymer can be 5% to 20% of the total adhesive composition. The butene component is a conjugated butadiene polymer appropriately selected from polybutadiene and polyisoprene. Polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). The hydrophilic colloid suitable for incorporation into the first composition is selected from naturally occurring hydrophilic colloids, semi-synthetic hydrophilic colloids and synthetic hydrophilic colloids. The first composition may contain 20% to 60% hydrophilic colloids. A preferred hydrophilic colloid is carboxymethyl cellulose (CMC). The first composition may optionally include other components such as fillers, tackifiers, plasticizers and other additives.

The first adhesive layer may have a plurality of sensor point openings. The sensor point opening of the first adhesive layer overlaps the (detection) portion of the electrode and is configured to form, for example, a sensor point.

The sensor point opening of the first adhesive layer may include a primary sensor point opening. The primary sensor point opening may include one or more primary sensor point openings and one or more second primary sensor point openings, where the first primary sensor point opening is of an electrode. The second primary sensor point opening is configured to overlap the (detection) portion so that the first primary sensor point opening overlaps the (detection) portion of another electrode that is at least partially overlapped with the electrode. It is composed.

The sensor point opening of the first adhesive layer may include a secondary sensor point opening. The secondary sensor point opening may include one or more primary secondary sensor point openings and one or more second secondary sensor point openings, the first secondary sensor point opening. Is configured to overlap the (detection) portion of the electrode, the second secondary sensor point opening is the (detection) of another electrode different from the electrode where the first secondary sensor point opening overlaps at least partially. ) It is configured to overlap the part.

The sensor point opening of the first adhesive layer may include a tertiary sensor point opening. The tertiary sensor point opening may include one or more first tertiary sensor point openings and one or more second tertiary sensor point openings, where the first tertiary sensor point opening is of an electrode. The second tertiary sensor point opening is configured to overlap the (detection) portion so that the first tertiary sensor point opening overlaps the (detection) portion of another electrode that is at least partially overlapped with the electrode. It is composed.

The first adhesive layer can have a substantially uniform thickness. The first adhesive layer can have a thickness in the range of 0.1 mm to 1.5 mm, such as 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0 mm.

The first adhesive layer may have a primary thickness in a primary portion of the first adhesive layer, eg, a primary radial distance from the center point of the stoma opening or a primary region within a primary radial distance range. The primary thickness can be in the range of 0.2 mm to 1.5 mm, such as about 1.0 mm. The primary radial distance can be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, and can be, for example, 30 mm.

The first adhesive layer has a secondary thickness in a secondary portion of the first adhesive layer, for example, in a secondary region separated by a secondary radial distance or a secondary radial distance range from the center point of the stoma opening. obtain. The secondary thickness can be in the range of 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance can be in the range of 20 mm to 50 mm, such as in the range of 25 mm to 35 mm, and can be, for example, 30 mm.

The base plate may include a second layer. The second layer can be an adhesive layer. The second layer may have a second radial spread that is greater than the first radial spread of the first adhesive layer, at least in the first angular range of the base plate. Thus, a portion of the proximal surface of the second layer may be configured to attach to the user's skin surface. The portion of the proximal surface of the second layer configured to attach to the user's skin surface is also referred to as the skin attachment surface of the second adhesive layer. The second layer may have a stoma opening with a center point.

The second adhesive layer can be made of the second composition. The second composition may comprise one or more polyisobutenes and / or styrene-isoprene-styrene. The second composition may include one or more hydrophilic colloids.

The second composition may be a pressure sensitive adhesive composition suitable for medical purposes, comprising an elastic elastomer base and one or more water-soluble or water-expandable hydrophilic colloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrophilic colloids, or any combination thereof. The combination of the adhesiveness of polybutene and the absorbency of hydrophilic colloids makes the second composition suitable for use in ostomy orthoses. The styrene copolymer can be, for example, a styrene butadiene styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block copolymers are utilized. The amount of styrene block copolymer can be 5% to 20% of the total adhesive composition. The butene component is a conjugated butadiene polymer appropriately selected from polybutadiene and polyisoprene. Polybutene is preferably present in an amount of 35% to 50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). The hydrophilic colloid suitable for incorporation into the second composition is selected from naturally occurring hydrophilic colloids, semi-synthetic hydrophilic colloids and synthetic hydrophilic colloids. The second composition may contain 20% to 60% hydrophilic colloids. A preferred hydrophilic colloid is carboxymethyl cellulose (CMC). The second composition may optionally include other components such as fillers, tackifiers, plasticizers and other additives.

The contents of different ratios can change the properties of the first and / or second adhesive layer. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different proportions of polyisobutene, styrene-isoprene-styrene and / or hydrophilic colloids. For example, the second adhesive layer may provide stronger adhesion to the skin as compared to the attachment to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer can be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may absorb less water and / or sweat than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less moldable than the first adhesive layer. The second adhesive layer may provide a second leak resistant barrier.

The second layer can have a substantially uniform thickness. The second layer has a thickness in the range of 0.1 mm to 1.5 mm, such as 0.5 mm, 0.6 mm or 0.7 mm, for example, a thickness in the range of 0.2 mm to 1.0 mm. obtain.

The base plate comprises one or more electrodes such as a plurality of electrodes such as 2, 3, 4, 5, 6 or 7 or more electrodes. Electrodes, such as some or all electrodes, may be placed between the first adhesive layer and the second adhesive layer. The electrodes may be placed in an electrode assembly, eg, an electrode layer. Electrodes include connections that connect the electrodes to other components and / or interface terminals / terminal elements. Electrodes may include one or more conductor portions and / or one or more detectors. The electrode assembly may be placed between the first adhesive layer and the second adhesive layer. The base plate, eg, the electrode assembly, may include a first electrode, a second electrode and optionally a third electrode. The base plate, eg, the electrode assembly, may include a fourth electrode and / or a fifth electrode. The base plate, eg, the electrode assembly, optionally includes a sixth electrode. The base plate, eg, the electrode assembly, may include a ground electrode. The ground electrode may include a first electrode portion. The first electrode portion of the ground electrode may form a ground or reference for the first electrode. The ground electrode may include a second electrode portion. The second electrode portion of the ground electrode may form a ground or reference for the second electrode. The ground electrode may include a third electrode portion. The third electrode portion of the ground electrode may form a ground or reference for the third electrode. The ground electrode may include a fourth electrode portion. The fourth electrode portion of the ground electrode may form a ground or reference for the fourth electrode and / or the fifth electrode.

The ground electrode or the electrode portion of the ground electrode can be configured as some or all (common) reference electrodes of some or all of the other electrodes in the electrode assembly, or can form a (common) reference electrode. The ground electrode is sometimes referred to as the reference electrode.

The electrodes are conductive, metallic materials (eg silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (eg ITO), polymer materials (eg PEDOT, PANI, PPy) and carbonaceous materials. It may contain one or more of the materials (eg, carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

The ground electrode portion may include a first electrode portion and a second electrode portion, the first electrode portion forms the ground of the first electrode, and the second electrode portion forms the ground of the second electrode. .. The first electrode portion may form a closed loop.

The electrodes are conductive and are metallic materials (eg silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (eg ITO), polymer materials (eg PEDOT, PANI, PPy) and carbonaceous materials. It may contain one or more of (eg, carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

The two electrodes in the electrode assembly can form a sensor. The first electrode and the ground electrode (for example, the first electrode portion of the ground electrode) may form a first sensor or a first electrode pair. The second electrode and the ground electrode (for example, the second electrode portion of the ground electrode) may form a second sensor or a second electrode pair. The third electrode and the ground electrode (for example, the third electrode portion of the ground electrode) may form a third sensor or a third electrode pair. The fourth electrode and the ground electrode (for example, the fourth electrode portion of the ground electrode) may form a fourth sensor or a fourth electrode pair. The fifth electrode and the ground electrode (for example, the fifth electrode portion of the ground electrode) may form a fifth sensor or a fifth electrode pair. The fourth electrode and the fifth electrode may form a sixth sensor or a sixth electrode pair.

The electrode may include one detection unit or a plurality of detection units, that is, a portion of the electrode used for detection. The first electrode may include a first detector. The first detector may come into contact with the first adhesive layer and is optionally arranged at least partially annularly around the stoma opening. The first electrode may include a first conductor portion, which is insulated from the first adhesive layer by a masking element disposed between the first conductor portion and the first adhesive layer. .. The first detector may extend at least 270 degrees around the stoma opening, eg, at least 300 degrees around the stoma opening. The first detection unit of the first electrode may be arranged at a first ground contact distance from the first electrode unit of the ground electrode. The first ground contact distance can be less than 5 mm, for example less than 3 mm, for example about 1.0 mm.

The second electrode may include a second detector. The second detector may come into contact with the first adhesive layer. The second detector is at least partially arranged around the stoma opening in an annular shape. The second detector may extend at least 270 degrees around the stoma opening, eg, at least 300 degrees around the stoma opening. The second detection portion of the second electrode may be arranged at a second ground contact distance from the second electrode portion of the ground electrode. The second ground contact distance can be less than 5 mm, for example less than 3 mm, for example about 1.0 mm.

The first detection unit may be located at a first radial distance from the center point, and the second detection unit may be located at a second radial distance from the center point. The second radial distance may be greater than the first radial distance. The second electrode may include a second conductor portion, which is insulated from the first adhesive layer by, for example, a masking element disposed between the second conductor portion and the first adhesive layer. NS. The first radial distance can vary depending on the angular position with respect to the zero direction from the center point. The second radial distance can vary depending on the angular position with respect to the zero direction from the center point. The zero direction can be defined as the vertical upward direction when the base plate is in the user's desired mounting position upright.

The first radial distance can be in the range of 5 mm to 40 mm, for example in the range of 10 mm to 25 mm, for example about 14 mm. The second radial distance can be in the range of 10 mm to 50 mm, for example in the range of 10 mm to 25 mm, for example about 18 mm.

The base plate may include a third electrode that includes a third connection. The ground electrode may form a ground for the third electrode. The ground electrode may include a third electrode portion, and the third electrode portion forms the ground of the third electrode. The third electrode may include a third conductor portion, which is insulated from the first adhesive layer by, for example, a masking element disposed between the third conductor portion and the first adhesive layer. .. The third electrode may include a third detector, which contacts the first adhesive layer. The third detector may be arranged at least partially in an annular shape around the stoma opening. The third detector may be located at a third radial distance from the center point. The third radial distance may be greater than the first radial distance and / or greater than the second radial distance. The third radial distance can be in the range of 15 mm to 50 mm, for example in the range of 20 mm to 30 mm, for example about 26 mm. The third detector may extend at least 270 degrees around the stoma opening, eg, at least 300 degrees around the stoma opening. The third detection unit of the third electrode is arranged at a third contact distance from the third electrode portion of the ground electrode. The third ground contact distance can be less than 5 mm, for example less than 3 mm, for example about 1.0 mm. A base plate with a ground electrode, a first electrode, a second electrode, and a third electrode is fail-safe if, for example, the first electrode is cut or otherwise destroyed during fabrication of the base plate. Can be the base plate of.

The base plate may include a fourth electrode that includes a fourth connection. The ground electrode may form a ground for the fourth electrode. The ground electrode may include a fourth electrode portion, and the fourth electrode portion forms the ground of the fourth electrode. The fourth electrode may include one or more fourth detectors, such as at least five fourth detectors. The fourth detector may be dispersed around the stoma opening or its central point. The fourth detection unit may be arranged at a fourth radial distance from the center point, respectively. The fourth radial distance may be greater than the third radial distance. The fourth radial distance can be in the range of 25 mm to 50 mm, for example about 30 mm.

The base plate may include a fifth electrode that includes a fifth connection. The ground electrode may form a ground for the fifth electrode. The ground electrode may include a fifth electrode portion, and the fifth electrode portion forms the ground of the fifth electrode. The fifth electrode may include one or more fifth detectors, such as at least five fifth detectors. The fifth detector may be dispersed around the stoma opening or its central point. The fifth detection unit may be arranged at a fifth radial distance from the center point, respectively. The fifth radial distance may be greater than the third radial distance. The fifth radial distance may be equal to or greater than the fourth radial distance. The fifth radial distance can be in the range of 25 mm to 50 mm, for example about 30 mm.

The first electrode may form an open loop. The second electrode can form an open loop and / or the third electrode can form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open-loop electrodes allow for electrode placement in a small number or one electrode layer.

The base plate may include a second adhesive layer, and the plurality of electrodes are arranged between the first adhesive layer and the second adhesive layer.

The electrode assembly may include a support layer, also referred to as a support film. One or more electrodes may be formed, eg, printed, on the proximal side of the support layer. One or more electrodes may be formed, eg, printed, on the distal side of the support layer. Therefore, one or more electrodes may be placed between the support layer and the first adhesive layer. The electrode assembly may have a stoma opening with a center point.

The support layer may include polymeric materials (eg, polyurethane, PTFE, PVDF) and / or ceramic materials (eg, alumina, silica). In one or more exemplary base plates, the support layer is made of thermoplastic polyurethane (TPU). The support layer material can be made of one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea and silicone, or can include one or more of them. ..

Examples of thermoplastic elastomers for the support layer are styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulture rubbers (TPV, TPE-v), and heat. Plastic polyurethane (TPU), thermoplastic co-polyester (TPC, TPE-E) and thermoplastic polyamide (TPA, TPE-A).

The electrode assembly / base plate may include a masking element configured to insulate at least a portion of the electrode from the first adhesive layer of the base plate. The masking element may include two or more sensor point openings, such as one or more. The sensor point opening may include a primary sensor point opening and / or a secondary sensor point opening. The sensor point opening may include a tertiary sensor point opening. The sensor point opening may include a quaternary sensor point opening. The sensor point opening of the masking element overlaps at least one of the electrodes of the electrode assembly when viewed in the axial direction, thereby forming, for example, a sensor point. For example, the primary sensor point opening may overlap the (detection) portion of the ground electrode and / or the (detection) portion of the fourth electrode. The secondary sensor point opening may overlap the (detection) portion of the fourth electrode and / or the (detection) portion of the fifth electrode. The tertiary sensor point opening may overlap the (detection) portion of the fifth electrode and / or the (detection) portion of the ground electrode.

The masking element may include two or more terminal openings, such as one or more. The terminal opening may overlap one or more connections of the electrodes. In one or more exemplary base plates, each terminal opening overlaps one connection of the electrodes.

The masking element may include polymeric materials (eg polyurethane, PTFE, PVDF) and / or ceramic materials (eg alumina, silica). In one or more exemplary base plates, the masking element is made of thermoplastic polyurethane (TPU) or comprises TPU. In one or more exemplary base plates, the masking element is made of polyester or comprises polyester. The masking element material can be made of one or more of polyester, thermoplastic elastomer (TPE), polyamide, polyimide, ethylene vinyl acetate (EVA), polyurea and silicone, or can include one or more of them. ..

Exemplary thermoplastic elastomers for masking elements include styrene block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic vulture rubbers (TPV, TPE-v), heat. Plastic polyurethane (TPU), thermoplastic co-polyester (TPC, TPE-E) and thermoplastic polyamide (TPA, TPE-A).

The base plate may include a first intermediate element. The first intermediate element may be located between the electrode / electrode layer and the first adhesive layer and / or between the second layer and the first adhesive layer. The first intermediate layer can be made of an insulating material.

The base plate may include a release liner. The release liner is a protective layer that protects the adhesive layer during transportation and storage and is removed by the user before applying the base plate to the skin. The release liner may have a stoma opening with a center point.

The base plate may include an upper layer. The upper layer is a protective layer that protects the adhesive layer from external strain and stress when the user wears the ostomy brace. Electrodes, such as some or all of the electrodes, may be placed between the first adhesive layer and the upper layer. The upper layer may have a stoma opening with a center point. The upper layer may have a thickness in the range of 0.01 mm to 1.0 mm, such as 0.04 mm, for example, a thickness in the range of 0.02 mm to 0.2 mm. The upper layer may have a stoma opening with a center point.

The base plate includes a monitor interface. The monitor interface may be configured to electrically and / or mechanically connect the ostomy appliance (base plate) to the monitor device. The monitor interface may be configured to wirelessly connect the ostomy brace (base plate) to the monitor device. Therefore, the monitor interface of the base plate is configured to electrically and / or mechanically couple the ostomy brace and the monitor device.

The monitor interface of the base plate may include, for example, a joint that forms a mechanical connection, such as an open bond between the monitor device and the base plate, as part of the first connector of the monitor interface. The joint may be configured to engage a monitor device joint that releasably couples the monitor device to the base plate.

The monitor interface of the base plate may be, for example, 2, 3, 4, 5, 6 or 7 or more terminals forming an electrical connection with each terminal of the monitor device as part of the first connector of the monitor interface. Can include multiple terminals. The monitor interface may include a ground terminal element that forms a ground terminal. The monitor interface may include a first terminal element forming a first terminal, a second terminal element forming a second terminal, and a third terminal element optionally forming a third terminal. The monitor interface may include a fourth terminal element forming a fourth terminal and / or a fifth terminal element forming a fifth terminal. The monitor interface optionally includes a sixth terminal element that forms the sixth terminal. The terminal elements of the monitor interface may contact each electrode (connection portion) of the base plate / electrode assembly. The first intermediate element may be placed between the terminal element and the first adhesive layer. The first intermediate element may cover or overlap the terminal element of the base plate when viewed in the axial direction. Therefore, the first adhesive layer is protected from the terminal elements of the base plate or is subject to more evenly distributed mechanical stresses from the terminal elements, thereby risking the terminal elements to penetrate the first adhesive layer. The risk of damaging the first adhesive layer in other ways can be reduced. The first intermediate element may protect the first adhesive layer from the terminal elements of the base plate or may mechanically and / or electrically shield it.

Terminal elements such as the grounded terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element are distal. It may include end and proximal ends. Terminal elements such as the grounded terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element are distal. It may include a portion, a central portion, and / or a proximal portion. The distal part can be between the distal end and the central part. The proximal part can be between the proximal end and the central part. The proximal / proximal portion of the terminal element may come into contact with the electrode connection. Terminal elements such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element, and / or the sixth terminal element are gold-plated. Can be copper.

The base plate may include a connecting ring or other connecting member that connects the ostomy pouch to the base plate (two-part ostomy brace). The center point can be defined as the center of the coupling ring.

The base plate has a stoma opening with a center point. The size and / or shape of the ostomy opening is usually adjusted by the user or nurse to suit the user's ostomy prior to application of the ostomy brace. In one or more exemplary base plates, the user forms a stoma opening while preparing the base plate for application.

The monitor device includes a processor. The processor controls the operation of the monitor device, which includes collecting and processing ostomy data from the base plate of the ostomy appliance, processing sensor data from the sensor unit, such as storage, and generating / transmitting monitor data to ancillary devices. included.

The monitor device includes memory for storing ostomy data and / or parameter data based on the ostomy data. The processor may be configured to process and store sensor data in memory.

The monitor device includes a monitor device housing optionally made of a plastic material. The monitor device housing can be an elongated housing having a first end and a second end. The monitor device housing may have a length in the range of 1 cm to 10 cm, i.e. the maximum spread along the longitudinal axis. The monitor device housing may have a width within the range of 0.5 cm to 5 cm, for example 0.8 cm to 3 cm, i.e., a maximum spread orthogonal to the longitudinal axis. The monitor device housing can be curved.

The monitor device housing may have a plurality of sensor openings, eg, a plurality of sensor openings for a sensor and / or a sensor opening for each of the sensors. The monitor device may include one or more sensor openings on the distal surface of the monitor device. The monitor device may include one or more sensor openings on the sides of the monitor device. The monitor device may include one or more sensor openings on the end face of the monitor device.

The sensor opening on the proximal surface is located at a distance from the first end to the sensor opening. The sensor opening distance, also referred to as D_S, can be in the range of 0.25L to 0.75L, for example 0.35L to 0.65L, where L is the length of the monitor device housing. The sensor opening distance can be in the range of 10 mm to 70 mm.

The monitor device housing includes or forms a sensor path from the periphery of the proximal surface to the first sensor surface. The sensor path transmits the temperature and / or humidity of the proximal surface of the monitor device / monitor device housing to the first sensor surface. Sensor aperture forms part of the sensor path having a cross-sectional area in the range of optionally 0.2 mm ² to 10 mm ^2. The sensor opening can be a circular sensor opening having a diameter in the range of 0.3 mm to 1.4 mm, for example 0.6 mm to 1.0 mm.

The monitor device includes a sensor unit having one or more sensors including a first sensor. The sensor unit is connected to the processor to supply the sensor data to the processor. The sensor unit may include a humidity sensor that provides humidity data to the processor. Therefore, the sensor data may include humidity data. For example, the first sensor can be a humidity sensor that provides humidity data to the processor. Therefore, the present disclosure allows for humidity detection near the user's skin and / or distal to the base plate, and can therefore be used for a more accurate estimate of the operating state of the base plate.

The sensor unit may include a temperature sensor that provides temperature data to the processor. Therefore, the sensor data may include temperature data. For example, the first sensor can be a temperature sensor that provides temperature data to the processor. Therefore, the present disclosure allows temperature detection near the user's skin and / or distal side of the base plate, which itself can be used for a more accurate estimate of the operating state of the base plate.

The first sensor can be a humidity and temperature composite sensor that provides humidity and temperature data to the processor.

The sensor unit of the monitor device may include a second sensor, eg, an accelerometer that provides acceleration data to the processor. The sensor unit of the monitor device may include a third sensor, eg, a gyroscope that provides gyroscope data to the processor. The sensor unit of the monitor device may include a fourth sensor, eg, a magnetometer that provides magnetometer data to the processor.

The processor is configured to process the ostomy data obtained from the base plate and generate or identify monitor data to be sent to ancillary devices. The monitor data may include sensor data obtained from the sensor unit.

The monitor device includes a first interface that connects the monitor device to the base plate. The first interface may be located on the proximal surface of the monitor device housing. The first interface may be located at a first interface distance from the first end. The first interface distance can be less than 0.50 L, for example less than 0.4 L, where L is the length of the monitor device housing.

The monitor device may include a sealing element that forms a seal between the first sensor and the housing portion of the monitor device housing. The sealing element can be, for example, an O-ring made of rubber material. The sealing element may surround the first sensor surface to expose the first sensor surface (membrane) to the sensor path, while providing a closed cavity for the monitoring device, which is a PCB, processor, and other. Accommodates electrical circuits. The glue can form a sealing element.

The ostomy system enables reliable and accurate measurement of various parameters related to the monitoring of ostomy orthoses. In the ostomy system, the distance between the proximal surface of the monitor device and the distal surface of the base plate is in the range of 0.2 mm to 10 mm, for example 0.5 mm to 5 mm, in the combined state. In the combined state, the monitor device is attached to the base plate and placed in its intended position during use of the ostomy system.

The monitor device includes a first interface connected to the processor. The first interface can be configured as a brace interface that electrically and / or mechanically connects the monitor device to the ostomy brace. Therefore, the brace interface is configured to electrically and / or mechanically couple the monitor device and the ostomy brace. The first interface may be configured as an ancillary device interface that electrically and / or mechanically connects the monitor device to an ancillary device such as a docking station. The first interface may be configured to be coupled to the docking of the ostomy system, for example for charging the monitor device and / or for data transmission between the monitor device and the docking station.

The first interface of the monitor device may include a plurality of terminals such as 2, 3, 4, 5, 6 or 7 or more terminals forming an electrical connection with each terminal and / or electrode of the ostomy appliance. One or more terminals of the first interface may be configured to form an electrical connection with ancillary devices, such as the terminals of a docking station. The first interface may include a ground terminal. The first interface may include a first terminal, a second terminal and optionally a third terminal. The first interface may include a fourth terminal and / or a fifth terminal. The first interface optionally includes a sixth terminal. In one or more exemplary monitor devices, the first interface has M terminals, where M is an integer in the range 4-8.

The first interface of the monitor device may include a mechanical connection between the monitor device and the base plate, eg, a joint forming an releasable bond. The joints and terminals of the first interface form (at least a portion of) the first connector of the monitor device.

The monitor device includes a power unit that supplies power to the monitor device. The power unit may include a battery. The power unit may include a charging circuit that is connected to the terminals of the battery and the first interface and charges the battery via the first interface, eg, the first connector. The first interface may include a separate charging terminal for charging the battery.

The monitor device includes a second interface connected to the processor. The second interface can be configured as an ancillary interface that connects the monitor device to one or more ancillary devices, eg, wirelessly. The second interface may include, for example, an antenna and a radio transceiver configured for wireless communication at frequencies in the range 2.4 GHz to 2.5 GHz. The wireless transmitter / receiver can be a Bluetooth® transmitter / receiver, i.e., the wireless transmitter / receiver can be a Bluetooth® protocol, such as Bluethoth® Low Energy, Bluetooth® 4.0, Bluetooth®. It may be configured for wireless communication according to (registered trademark) 5. The second interface optionally includes a loudspeaker and / or a haptic feedback element that provides the user with an audio signal and / or haptic feedback, respectively. The processor may be configured to transmit monitor data as a wireless monitor signal via an antenna and a wireless transceiver.

The ostomy system may include a docking station that forms ancillary devices to the ostomy system. The docking station may be configured to electrically and / or mechanically couple the monitor device to the docking station.

The docking station may include a docking monitor interface. The docking monitor interface may be configured to electrically and / or mechanically couple the monitor device to the docking station. The docking monitor interface may be configured to wirelessly connect the monitor device to the docking station. The docking monitor interface of the docking station may be configured to electrically and / or mechanically couple the docking station and the monitoring device.

The docking monitor interface of the docking station may include, for example, a coupling portion that forms a mechanical connection, such as an openable coupling between the monitoring device and the docking station, as part of the first connector of the docking monitor interface. The coupling may be configured to engage the coupling of the monitor device to releasably couple the monitor device to the docking station.

The docking monitor interface of the docking station is, for example, 2, 3, 4, 5, 6 or 7 or more forming an electrical connection with each terminal of the monitor device as part of the first connector of the docking monitor interface. It may include multiple terminals such as terminals. The docking monitor interface may include a ground terminal. The docking monitor interface may include a first terminal and / or a second terminal. The docking station may include a third terminal. The docking monitor interface may include a fourth terminal and / or a fifth terminal. The docking monitor interface optionally includes a sixth terminal.

Ancillary devices include memory, a processor, and an interface coupled to the processor. The interface includes a display such as a touch-sensitive display and a transceiver unit.

The interface / transceiver unit of the accessory device is configured to communicate with the monitor device and / or the server device. The interface of the ancillary device may be configured to communicate with the server device over the network.

The interface of the accessory device can be configured as a monitor interface that connects the accessory device to one or more monitor devices, for example, wirelessly. The interface of the accessory device may include, for example, a transceiver unit including an antenna and a radio transceiver configured for wireless communication at frequencies in the range 2.4 GHz to 2.5 GHz. The wireless transceiver can be a Bluetooth® transmitter / receiver, i.e. the wireless transceiver can be a Bluetooth® protocol, such as Bluetooth® Low Energy, Bluetooth® 4.0, Bluetooth (registered trademark). It can be configured for wireless communication with registered trademark) 5.

Ancillary devices are configured to receive monitor data from one or more monitor devices. Ancillary devices can be configured to send ancillary data, for example, to a server device. For example, the processor of ancillary devices may be configured to transmit ancillary data as a wireless ancillary signal via an antenna and a wireless transceiver.

The interface of the attached device includes a display. The interface of the attached device is configured to acquire monitor data from the monitor device coupled to the ostomy device, for example, via a transceiver unit. The monitor data may include sensor data obtained from one or more sensors in the monitor device. The monitor data may include ostomy data obtained from the electrodes of the base plate and / or parameter data based on the ostomy data obtained from the electrodes of the base plate. The parameter data can indicate the voltage between each electrode pair of the base plate (and therefore the resistance). The parameter data can indicate the current between each electrode pair of the base plate (and therefore the resistance).

The monitor data may indicate the status or operating condition of the ostomy orthosis, eg, the status or operating condition of the base plate disclosed herein. The status or operating condition of an ostomy orthosis, or of the base plate disclosed herein, is the level of at least a portion of the physical properties of the ostomy orthosis, such as the level of moisture and / or temperature of at least a portion of the base plate, eg. The level of physical properties of at least one layer of the base plate, such as the level of moisture and / or temperature of at least one layer of the base plate, such as the level of physical properties of at least the adhesive layer of the base plate (eg, proximal to the user's skin). First adhesive layer). In one or more exemplary accessory devices, the interface is monitor data indicating a condition or operating condition that includes the moisture level of the first adhesive layer of the base plate and / or the proximal side of the first adhesive layer. Is configured to acquire monitor data by acquiring. Moisture levels can be seen as representing conductive paths within the first adhesive layer, eg, across the first adhesive layer. The monitor data includes, for example, data representing measured values of electrical properties of the first adhesive layer. In other words, the situation can be seen as the situation of the first adhesive layer.

User interface, as used herein, refers to a graphical representation that includes a set of user interface objects. The user interface includes one or more user interface objects. The user interface may also be referred to as a user interface screen.

A user interface object, as used herein, refers to a graphical representation of an object displayed on the display of ancillary devices. User interface objects can be selectable by user interactive or user input. For example, images (eg, icons), buttons, and text (eg, hyperlinks) each optionally constitute a user interface object. User interface objects can form part of a widget. Widgets can be viewed as mini-applications that can be used and created by the user. User interface objects may include prompts, application launch icons, and / or action menus. Inputs such as the first input and / or the second input may include touches (eg, taps, force touches, long presses) and / or movements of contacts (eg, swipe gestures to toggle). Touch movement can be detected by a touch-sensitive surface, such as the display of ancillary devices. Therefore, the display can be a touch sensitive display. Inputs such as the first input and / or the second input may include lift-off. Inputs such as the first input and / or the second input may include touches and movements followed by lift-off.

The display of the accessory device may be configured to detect touch (eg, the display is a touch sensitive display) and the input involves contact with the touch sensitive display. The touch-sensitive display provides an input interface and an output interface between the attached device and the user. The processor of the ancillary device may be configured to receive an electrical signal from the touch-sensitive display and / or transmit the electrical signal to the touch-sensitive display. Touch-sensitive displays are configured to display visual output to the user. The visual output optionally includes graphics, text, icons, videos, and any combination thereof (collectively referred to as "graphics"). For example, some or all of the visual output can be seen as corresponding to a user interface object.

The processor of the accessory device may be configured to display one or more user interfaces, such as a user interface screen, on the display, including a first user interface and / or a second user interface. The user interface may include one or more user interface objects, such as a plurality. For example, the first user interface may include a first user interface object. A user interface object, such as the first user interface object, may represent the operating state of the base plate.

For example, devices for or ancillary to an ostomy system including a monitor device and an ostomy brace are disclosed, the ostomy brace includes a base plate. Ancillary devices include memory, a processor, and an interface that is coupled to the processor and configured to communicate with the monitor device. The interface includes a display and is configured to retrieve monitor data from a monitor device coupled to the ostomy appliance, which includes sensor data. The monitor data optionally includes one or more of the ostomy data obtained from the electrodes of the base plate and parameter data based on the ostomy data obtained from the electrodes of the base plate. Sensor data is acquired from one or more sensors in the monitor device. The processor of the attached device determines the operating state of the base plate based on one or more of the sensor data and / or the ostomy data and the parameter data based on the ostomy data, and displays the operating state of the base plate on the display. It is configured to display a first user interface that includes a user interface object.

Improved by enabling better classification of moisture patterns (adhesive performance) and moisture propagation in the adhesive layer of the base plate by determining the operating state of the base plate based on both ostomy data / parameter data and sensor data of the monitor device. It is possible to judge the operation state that has been performed. For example, the sensor data of the monitor device can contribute to determining the cause of the ostomy data measured on the base plate.

Users or healthcare professionals of ostomy equipment should be provided with improved tools for monitoring and planning the use of ostomy equipment in their daily lives by utilizing the sensor data of the monitoring device acquired by the attached device. Is an advantage of the present disclosure. The present disclosure improves the accuracy of monitoring and prediction of the performance of ostomy orthoses with improved user comfort. According to the present disclosure, it is possible to derive the operating state more accurately from the sensor data of the monitor device which is considered to affect the operating state. In other words, the disclosed method and ancillary devices can predict and show the user the dynamic internal state of the base plate, which allows the user to coordinate the use of the ostomy brace with the planning of activities of daily living. Assist.

The operating state of the base plate in the present disclosure indicates the dynamic internal state of the base plate of the ostomy orthosis currently worn by the user, and optionally relates to the adhesive performance of the base plate. The adhesive performance of the ostomy orthosis may relate to the internal condition of the base plate of the ostomy orthosis, for example, the internal condition of the adhesive layer of the base plate. Adhesive performance and thus operating conditions can be affected by several factors such as humidity, temperature, misalignment of the ostomy brace on the ostomy and / or malfunction of the ostomy brace. One or more factors affect the (current and / or future) adhesion performance of the ostomy orthosis base plate alone or together. The operating state can change with time. The operating state may indicate the degree of erosion of the base plate.

Adhesive performance can indicate wearing characteristics, such as wearing time and / or wearing comfort. The operating state may include at least one of wearing time, adhesion quality, and moisture pattern representation. The wearing time may include any other statistical metric that can be derived from the average wearing time, the nominal wearing time, the minimum wearing time, the maximum wearing time, the median wearing time, and / or the wearing time. The wearing time may include the remaining wearing time and / or the current wearing time and / or the elapsed wearing time. Adhesive quality can include metrics that indicate erosion of some layer of the base plate, eg, the first adhesive layer.

The operating state can be configured to indicate whether the ostomy orthosis or its base plate can operate properly based on its adhesive performance (eg, wearing characteristics, such as wearing time and / or wearing comfort). For example, the operating state may indicate the severity and / or urgency of the leak (eg, low, medium, serious). The operating state may include Z operating states, where Z is an integer. The operating state may include a first operating state, a second operating state, and / or a third operating state (eg, good, check, within X hours / replace now).

The processor may be configured to display a first user interface on the display, including a first user interface object representing the operating state of the base plate, depending on the display criteria being met.

In the attached device, determining the operating state of the base plate based on the sensor data and one or more of the ostomy data and the parameter data based on the ostomy data can be used to determine the expected remaining mounting time of the base plate, such as the sensor data and / or It may include making a decision based on one / or more of the ostomy data and the parameter data based on the ostomy data. The first user interface object may represent the expected remaining mounting time of the base plate.

In one or more exemplary accessory devices, the display criteria may be met when the expected remaining mounting time of the base plate is less than the display threshold, eg, less than 2 hours.

In ancillary devices, determining the expected remaining mounting time of the base plate may include determining a change in the current expected remaining mounting time of the base plate. The expected remaining mounting time of the base plate can be based on changes in the current expected remaining mounting time and the current expected remaining mounting time.

In ancillary devices, determining the expected remaining mounting time of the base plate may include increasing the current expected remaining mounting time of the base plate as the increasing criteria set is met. The growth criterion set may include one or more growth criteria.

In ancillary devices, determining the expected remaining mounting time of the base plate may include reducing the current expected remaining mounting time of the base plate as the reduction criteria set is met. The reduction criteria set may include one or more reduction criteria.

In ancillary devices, at least the first augmentation criterion of the augmentation criterion set may be based on sensor data. The second and / or third increment criteria may be based on sensor data. In ancillary devices, at least the first growth criterion of the growth criterion set may be based on ostomy data and / or parameters based on ostomy data. The second and / or third growth criterion may be based on ostomy data and / or parameters based on the ostomy data.

The sensor data may include the humidity data of the humidity sensor of the monitor device, and the operating state of the base plate is optionally based on the humidity data. Therefore, one or more augmentation criteria in the augmentation criteria set may be based on the humidity data of the monitor device.

In one or more exemplary ancillary devices, the processor is configured to increase the current expected remaining mounting time of the base plate in response to the increase criteria set being met, which is the humidity data. Is satisfied, for example, when the humidity value is higher than the first humidity threshold value over the first period less than the first time threshold value. Therefore, an increase in humidity over a limited period of time can contribute to an increase in base plate mounting time, which increases the expected remaining mounting time of the base plate.

In one or more exemplary ancillary devices, the processor is configured to increase the current expected remaining mounting time of the base plate in response to the increase criteria set being met, which is the humidity data. Is satisfied, for example, when the humidity value is lower than the second humidity threshold value over a second period exceeding the second time threshold value. Therefore, a decrease in humidity over a second period longer than the second time threshold can contribute to an increase in base plate mounting time, which increases the expected remaining mounting time of the base plate.

In one or more exemplary ancillary devices, the processor is configured to reduce the current expected remaining mounting time of the base plate as the reduction criteria set is met, and the reduction criteria set is the humidity data. Is satisfied, for example, when the humidity value is higher than the third humidity threshold value over a third period exceeding the third time threshold value. Therefore, an increase in humidity over a long period of time can contribute to a reduction in base plate mounting time, which reduces the expected remaining mounting time of the base plate.

The sensor data may include the temperature data of the temperature sensor in the monitor device, and the operating state of the base plate is optionally based on the temperature data. Therefore, one or more augmentation criteria in the augmentation criteria set may be based on the temperature data of the monitor device.

In one or more exemplary ancillary devices, the processor is configured to increase the current expected remaining mounting time of the base plate in response to the increase reference set being met, which is the temperature data. Is satisfied, for example, when the temperature value is higher than the first temperature threshold value over the first period less than the first time threshold value. Therefore, an increase in temperature over a limited period of time can contribute to an increase in base plate mounting time, which increases the expected remaining mounting time of the base plate.

In one or more exemplary ancillary devices, the processor is configured to reduce the current expected remaining mounting time of the base plate as the reduction reference set is met, and the reduction reference set is the temperature data. Is satisfied, for example, when the temperature value is higher than the third temperature threshold value over a third period exceeding the third time threshold value. Therefore, an increase in temperature over a long period of time can contribute to a reduction in base plate mounting time, which reduces the expected remaining mounting time of the base plate.

The sensor data may include the acceleration data of the accelerometer in the monitor device, and the operating state of the base plate is based on the acceleration data. Therefore, one or more augmentation criteria in the augmentation criterion set may be based on the acceleration data of the monitor device.

The sensor data may include the gyroscope data of the gyroscope in the monitor device, and the operating state of the base plate is based on the gyroscope data. Therefore, one or more growth criteria in the growth criterion set may be based on the gyroscope data of the monitor device.

The sensor data may include magnetometer data of the magnetometer in the monitor device, and the operating state of the base plate is based on the magnetometer data. Therefore, one or more augmentation criteria in the augmentation criteria set may be based on the magnetometer data of the monitor device.

Acceleration data, gyroscope data, and / or magnetometer data can indicate the user's activity level. The processor may be configured to determine the user's activity level based on, for example, accelerometer data, gyroscope data, and / or magnetometer data. Therefore, one or more augmentation criteria in the augmentation criterion set may be based on the gyroscope data and / or magnetometer data of the monitor device. Experimental results show that the base plate wearing time (and therefore the remaining wearing time of the base plate as an operating state) is due to high activity levels (eg, sports, bending, stretching, movement) when the user is at all or barely active. It has been demonstrated that it can be affected by a reduction factor of 2-10 compared to (eg, a sitting user). For example, total wearing time can be reduced by a factor of 2-10 with high or strenuous exercise levels, thus affecting base operating time, eg remaining wearing time.

In one or more exemplary ancillary devices, the processor is configured to increase the current expected remaining mounting time of the base plate as the augmentation reference set is met, and the augmentation reference set is the acceleration data. , Gyroscope data and / or magnetometer data are satisfied when they exhibit an activity level lower than the first activity threshold, eg, over a first period longer than the first time threshold. Therefore, a decrease in activity over a long period of time can contribute to an increase in base plate mounting time, which increases the expected remaining mounting time of the base plate.

The first user interface object can be a notification, for example the first user interface is the lock screen or home screen of ancillary devices.

The first user interface object can be an application launch icon and the first user interface can be a home screen.

The first user interface can be an application user interface for an application running on ancillary devices.

Also disclosed are methods that are performed within an ostomy system's ancillary devices, the ancillary device including an interface configured to communicate with one or more devices of the ostomy system, the interface including a display, and the ostomy system. Includes a monitor device and / or an ostomy device configured to be placed on the user's skin surface, the ostomy device includes a base plate. The method is to acquire monitor data, which is the sensor data, one or more of the ostomy data acquired from the base plate electrodes, and the parameter data based on the ostomy data obtained from the base plate electrodes. Including, the sensor data is obtained from one or more sensors in the monitor device, and the operating state of the base plate is determined based on the sensor data and the parameter data based on one or more of the ostomy data and the ostomy data. It includes determining and displaying a first user interface on the display that includes a first user interface object that represents the operating state of the base plate.

In the method, determining the operating state of the base plate based on the sensor data and one or more of the ostomy data and the parameter data based on the ostomy data is the parameter data based on the sensor data and one or more of the ostomy data and the ostomy data. The first user interface object may represent the expected remaining mounting time of the base plate, which may include determining the expected remaining mounting time of the base plate based on.

In the method, determining the expected remaining mounting time of the base plate may include determining a change in the current expected remaining mounting time of the base plate, and determining the expected remaining mounting time of the base plate may include determining the current expected remaining mounting time. Based on changes in time and current expected remaining wearing time.

In the method, determining the expected remaining mounting time of the base plate may include increasing the current expected remaining mounting time of the base plate as the increasing criteria set is met.

FIG. 1 shows an exemplary ostomy system. The ostomy system 1 includes an ostomy brace 2 that includes a base plate 4 and an ostomy pouch (not shown). Further, the ostomy system 1 includes a monitor device 6 and an accessory device 8 (mobile phone). The base plate 4 and the monitor device 6 are in a coupled state, and the monitor device 6 can be connected to the base plate 4 via the first connector of each of the monitor device 6 and the base plate 4. The monitor device 6 is configured to wirelessly communicate with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with the server device 10 of the ostomy system 1 via, for example, the network 12. The server device 10 may be operated and / or controlled by the ostomy equipment manufacturer and / or service center. The ostomy data or the parameter data based on the ostomy data is acquired from the electrodes / sensors of the ostomy device 2 having the monitor device 6. The monitor device 6 processes the ostomy data and / or the parameter data based on the ostomy data to identify the monitor data to be transmitted to the attached device 8. The monitor data may include sensor data of the monitor device. In the ostomy system of the figure, the accessory device 8 is a mobile phone or smartphone, but the accessory device 8 can be implemented as a tablet device or another handheld device such as a wearable such as a wristwatch or other wrist-worn electronic device. Therefore, the monitor device 6 is configured to identify the monitor data and transmit it to the attached device 8. The base plate 4 includes a connecting member 14 in the form of a connecting ring 16 that connects the ostomy pouch (not shown) to the base plate (two-part ostomy brace). The base plate 4 has a stoma opening 18 having a stoma center point 19. The size and / or shape of the ostomy opening 18 is usually adjusted by the user or nurse to fit the user's ostomy prior to application of the ostomy brace.

The ostomy system 1 optionally includes a docking station 20 that forms an accessory device of the ostomy system 1. The 20 including the docking station includes a docking monitor interface including a first connector 22 configured to electrically and / or mechanically connect the monitor device 6 to the docking station 20. The docking monitor interface may be configured to wirelessly connect the monitor device to the docking station. The docking station 20 includes a user interface 24 that receives user input and / or provides feedback to the user about the operating state of the docking station 20. The user interface 24 may include a touch screen. The user interface 24 may include one or more physical buttons and / or one or more visual indicators such as light emitting diodes.

FIG. 2 is a block diagram of an exemplary monitor device. The monitor device 6 includes a monitor device housing 100, a processor 101, and one or more interfaces, and the one or more interfaces include a first interface 102 (equipment interface) and a second interface 104 (attached interface). )including. The monitor device 6 includes a memory 106 that stores ostomy data and / or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and / or the first interface 102.

The first interface 102 is configured as an orthosis interface that electrically and / or mechanically connects the monitor device 6 to an ostomy orthosis, such as an ostomy orthosis 2. The first interface 102 includes a plurality of terminals forming an electrical connection with each terminal of the ostomy device 2 (base plate 4). The first interface 102 includes a ground terminal 108, a first terminal 110, a second terminal 112, and a third terminal 114. The first interface 102 optionally includes a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 includes a coupling portion 120 that forms a mechanical connection, such as an open coupling between the monitor device and the base plate. The coupling 120 and the terminals 108, 110, 112, 114, 116 and 118 of the first interface 102 form (at least a portion of) the first connector of the monitor device 6.

The monitor device 6 includes a power unit 121 that feeds the monitor device and its active components, that is, the power unit 121 is connected to a processor 101, a first interface 102, a second interface 104, and a memory 106. The power unit includes a battery and a charging circuit. The charging circuit is connected to the terminal of the battery and the first interface 102, and charges the battery via the terminal of the first interface, for example, the terminal of the first connector.

The second interface 104 of the monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices such as the accessory device 8. The second interface 104 includes an antenna 122 and a wireless transceiver 124 configured to wirelessly communicate with ancillary devices. Optionally, the second interface 104 includes a loudspeaker 126 and / or a haptic feedback element 128 that provides the user with audio signals and / or haptic feedback, respectively.

The monitor device 6 optionally includes a sensor unit 140 that is connected to the processor 101 and provides sensor data 142 to the processor 101. The sensor unit 140 includes a first sensor 144, which is a temperature and humidity sensor that supplies temperature and humidity data as sensor data 142 to the processor 101. Further, the sensor unit 140 includes a second sensor 146, which is an accelerometer that supplies acceleration data as sensor data 142 to the processor 101. The processor 101 receives the sensor data 142 including the temperature data, the humidity data, and the acceleration data, stores the sensor data 142 in the memory 106, and / or transmits the sensor data as a part of the monitor data via the second interface 104.

The monitor device 100 is configured to acquire ostomy data from a base plate coupled to the first interface 102. The ostomy data can be stored in memory 106 and / or processed in processor 101 to obtain parameter data based on the ostomy data.

FIG. 3 shows an exploded view of an exemplary base plate of an ostomy brace. The base plate 4 includes a first adhesive layer 200 having a stoma opening 18A. During use, the proximal surface of the first adhesive layer 200 adheres to the user's skin in the area surrounding the stoma and / or additional encapsulation such as encapsulating paste, encapsulating tape, and / or encapsulating ring. The base plate 4 optionally includes a second adhesive layer 202 having a stoma opening 18B. The base plate 4 includes a plurality of electrodes arranged in the electrode assembly 204. The electrode assembly 204 is arranged between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 includes a support layer having a stoma opening 18C and electrodes formed on the proximal surface of the support layer. The base plate 4 includes a release liner 206 that is peeled off by the user prior to applying the base plate 4 to the skin. The base plate 4 includes an upper layer 208 having a stoma opening 18D and a coupling ring 209 that binds the ostomy pouch to the base plate 4. The upper layer 208 is a protective layer that protects the second adhesive layer 202 from external strain and stress during use.

The base plate 4 includes a monitor interface. The monitor interface is configured to electrically and / or mechanically connect the ostomy appliance (base plate 4) to the monitor device. The monitor interface of the base plate includes a coupling portion 210 that forms a mechanical connection such as an open coupling between the monitoring device and the base plate. The coupling portion 210 is configured to engage the coupling portion of the monitor device to releasably couple the monitor device to the base plate 4. Further, the monitor interface of the base plate 4 includes a plurality of terminals each forming a plurality of terminals 212 forming an electrical connection with each terminal of the monitor device. The coupling portion 210 and the terminal 212 form the first connector 211 of the base plate 4. The base plate 4 includes a first intermediate element 213 on the distal side of the electrode assembly. The first intermediate element 213 is arranged between the terminal element forming the terminal 212 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal element forming the terminal 212 of the base plate 4 when viewed in the axial direction, and protects the first adhesive layer from mechanical stress from the terminal element of the base plate 4.

FIG. 4 shows an exploded view of an exemplary electrode assembly 204 of the base plate. The electrode assembly 204 has a distal side 204A and a proximal side 204B. The electrode assembly 204 is arranged on the proximal side of the support layer 214 having the proximal surface 214B and the support layer 214, and is a ground electrode, a first electrode, a second electrode, a third electrode, and a fourth electrode. , And an electrode 216 including a fifth electrode, each electrode having a connecting portion 217 connecting the electrode 216 to each terminal element of the monitor interface. Electrodes 216 are positioned and / or formed on the proximal side 214B of the support layer 214. Further, the electrode assembly 204 has a proximal surface 218B and includes a masking element 218 configured to insulate the electrode portion of the electrode 216 from the first adhesive layer of the base plate. The masking element 218 covers or overlaps the portion of the electrode 216 when viewed in the axial direction.

FIG. 5 is a proximal view of the proximal surface of the base plate portion of the base plate without the first adhesive layer and release liner. The base plate 4 includes a first intermediate element 213 on the distal side of the electrode assembly, i.e., between the electrode assembly 204 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal element of the base plate 4 when viewed in the axial direction and protects the first adhesive layer from mechanical stress from the terminal element of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 of the electrode 216 of the electrode assembly 204. The electrode configuration 220 / electrode assembly 204 includes a ground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230 and a fifth electrode 232. The ground electrode 222 includes a ground connection portion 222A, and the first electrode 224 includes a first connection portion 224A. The second electrode 226 includes a second connecting portion 226A, and the third electrode 228 includes a third connecting portion 228A. The fourth electrode 230 includes a fourth connecting portion 230A, and the fifth electrode 232 includes a fifth connecting portion 232A.

The fourth electrode 230 includes a fourth detection unit 230B. The fifth electrode 232 includes a fifth detection unit 232B.

The ground electrode 222 includes a first electrode portion 234 that forms a ground or reference for the first electrode 224. The ground electrode 222 includes a second electrode portion 236 that forms a ground or reference for the second electrode 226. The ground electrode 222 includes a third electrode portion 238 that forms a ground or reference for the third electrode 228. The masking element 218 is located proximal to the electrodes 222, 224, 226, 228, covers the portion of the electrode, insulates it from the first adhesive layer, and provides each conductor portion of the electrodes 222, 224, 226, 228. Form. The portions of the electrodes 222, 224, 226, and 228 that are not covered by the masking element 219 come into contact with the first adhesive layer to form the detection portions 224B, 226B, and 228B of the electrodes 224, 226, and 228, respectively. Further, the electrode portions 234, 236, and 238 form a detection portion of the ground electrode 222.

The first detection unit 224B extends circularly at least 330 degrees around the stoma opening at a first radial distance R1 from the center point 19. The first radial distance R1 can be about 14 mm. In one or more embodiments, the first radial distance R1 can be about 13 mm, such as 12.5 mm. The first electrode unit 234 is arranged inside the first detection unit (that is, closer to the center), and the stoma opening (in the radial direction from the center point) at the first ground contact distance RG1 from the first detection unit. It extends at least 330 degrees in a circle around the section. The first ground contact distance RG1 between the detection unit of the first electrode and the first electrode unit is about 1 mm.

The second detector 226B extends circularly at least 330 degrees around the stoma opening at a second radial distance R2 from the center point 19. The second radial distance R2 can be 18 mm. In one or more embodiments, the second radial distance R2 can be 17 mm. The second electrode unit 236 is arranged inside the second detection unit 226B (that is, closer to the center), and is located at a second ground contact distance RG2 from the second detection unit 226B (in the radial direction from the center point). It extends in a circle of at least 330 degrees around the stoma opening. The second ground contact distance RG2 between the detection unit of the second electrode and the second electrode unit is about 1 mm.

The third detector 228B extends circularly at least 330 degrees around the stoma opening at a third radial distance R3 from the center point 19. The third radial distance R3 is about 26 mm. In one or more embodiments, the third radial distance R3 is 21 mm. The third electrode unit 238 is arranged inside the third detection unit 228B (that is, closer to the center), and is located at a third ground contact distance RG3 from the third detection unit 228B (in the radial direction from the center point). It extends in a circle of at least 330 degrees around the stoma opening. The third contact distance RG3 between the detection unit and the third electrode portion of the third electrode is about 1 mm.

The ground electrode 222 includes a fourth electrode portion 240 that forms a ground or reference for the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the ground electrode 222 extends at least 300 degrees around the stoma opening and includes the ground detector 222B. The grounding detection unit of the fourth detection unit 230B, the fifth detection unit 232B, and the fourth electrode unit 240 has a center point 19 at a leakage radius (such as a leakage radius R5 that can be about 32 mm from the center point) from the center point. It is distributed in a circle around. The fourth detection unit 230B, the fifth detection unit 232B, and the grounding detection unit of the fourth electrode unit have a radius of more than 1.0 mm in the range of 1.5 mm to 3.0 mm, for example, about 2.0 mm. Can have spread. The grounding detection unit of the fourth detection unit 230B, the fifth detection unit 232B, and the fourth electrode unit 240 is in the range of 2.5 mm to 5.0 mm, for example, 1.0 mm such as about 3.5 mm. It can have a super circumferential spread (perpendicular to the radial spread).

FIG. 7 is a distal view of an exemplary masking element. The masking element 218 optionally has a plurality of terminal openings including six terminal openings. The plurality of terminal openings include a ground terminal opening 242, a first terminal opening 244, a second terminal opening 246, a third terminal opening 248, a fourth terminal opening 250, and a fifth terminal opening. Includes part 252. The terminal openings 242, 244, 246, 248, 250, 252 of the masking element 218 overlap and / or align with the electrode connections 222A, 224A, 226A, 228A, 230A, 232A of the electrode assembly. It is configured as follows.

The masking element 218 has a plurality of sensor point openings. The sensor point openings include the primary sensor point openings shown within the dotted line 254, and each primary sensor point opening is configured to overlap a portion of the ground electrode 222 and / or a portion of the fourth electrode 230. .. The primary sensor point opening 254 includes, in the exemplary masking element shown, five first primary sensor point openings 254A, each configured to overlap a portion of the ground electrode 222. The primary sensor point opening 254 includes, in the exemplary masking element shown, four second primary sensor point openings 254B, each configured to overlap a portion of the fourth electrode 230. The sensor point openings include the secondary sensor point openings shown within the dotted line 256 so that each secondary sensor point opening overlaps a portion of the fourth electrode 230 and / or a portion of the fifth electrode 232. It is composed of. The secondary sensor point opening 256 includes, in the exemplary masking element shown, five first secondary sensor point openings 256A, each configured to overlap a portion of the fifth electrode 232. The secondary sensor point opening 256 includes, in the exemplary masking element shown, four second secondary sensor point openings 256B, each configured to overlap a portion of the fourth electrode 230. The sensor point openings include the tertiary sensor point openings shown within the dotted line 258, and each tertiary sensor opening is configured to overlap a portion of the fifth electrode 232 and / or a portion of the ground electrode 222. The tertiary sensor point opening 258 includes, in the exemplary masking element shown, five first tertiary sensor point openings 258A, each configured to overlap a portion of the fifth electrode 232. The tertiary sensor point opening 258 includes, in the exemplary masking element shown, four second tertiary sensor point openings 258B, each configured to overlap a portion of the ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensor point openings. The sensor point openings of the first adhesive layer include the primary sensor point openings shown within the dotted line 260, and each primary sensor point opening is a portion of the ground electrode 222 of the electrode assembly and / or a fourth electrode. It is configured to overlap the 230 portion. The primary sensor point openings include five primary sensor point openings 260A, each configured to overlap a portion of the ground electrode 222 in the exemplary first adhesive layer shown. The primary sensor point opening includes four second primary sensor point openings 260B, each configured to overlap a portion of the fourth electrode 230 in the exemplary first adhesive layer shown. The sensor point openings of the first adhesive layer include the secondary sensor point openings shown within the dotted line 262, and each secondary sensor point opening is a portion of the fourth electrode 230 of the electrode assembly and / or It is configured to overlap the portion of the fifth electrode 232. The secondary sensor point opening includes five first secondary sensor point openings 262A, each configured to overlap a portion of the fifth electrode 232 in the exemplary first adhesive layer shown. The secondary sensor point opening includes four second secondary sensor point openings 262B, each configured to overlap a portion of the fourth electrode 230 in the exemplary first adhesive layer shown. The sensor point openings of the first adhesive layer include the tertiary sensor point openings shown within the dotted line 264, and each tertiary sensor opening is a portion of the fifth electrode 232 and / or ground electrode 222 of the electrode assembly. It is configured to overlap the part of. The tertiary sensor point opening includes five first tertiary sensor point openings 264A, each configured to overlap a portion of the fifth electrode 232 in the exemplary first adhesive layer shown. The tertiary sensor point opening includes four second tertiary sensor point openings 264B, each configured to overlap a portion of the ground electrode 222 in the exemplary first adhesive layer shown. FIG. 9 is a proximal view of the first adhesive layer of FIG.

FIG. 10 is a more detailed distal view of the base plate 4. The base plate monitor interface includes a first connector 211. The first connector 211 includes a coupling portion 210 that is configured to releasably couple the monitor device to the base plate, thereby forming an releasable bond. The first connector 211 / monitor interface includes a plurality of terminals formed by each terminal element forming each electrical connection with each terminal of the monitor device.

The plurality of terminals of the first connector 211 / monitor interface form a ground terminal element 282 forming the ground terminal 282A, a first terminal element 284 forming the first terminal 284, and a second terminal 286A forming the second terminal 286A. Includes a third terminal element 286, and optionally a third terminal element 288 that forms a third terminal 288A. The monitor interface optionally includes a fourth terminal element 290 forming the fourth terminal 290A and / or a fifth terminal element 292 forming the fifth terminal 290. The terminal elements 282, 284, 286, 288, 290, and 292 come into contact with the connecting portions 222A, 224A, 226A, 228A, 230a, and 232A of the electrodes 222, 224, 226, 228, 230, and 232.

The position of the first connector on the base plate, the number of terminals at the joint and the position of the terminals can be adapted to the electrode configuration used in the electrode assembly of the base plate.

FIG. 11 is a block diagram illustrating an exemplary accessory device 8 according to the present disclosure. The attached device 8 forms a part of the ostomy system 1, determines the operating state of the ostomy device 2 installed on the user's skin, and particularly determines the operating state of the base plate 4 of the ostomy device 6 (see FIG. 1). It can be judged based on the sensor data of. The accessory device 8 includes a memory 301, a processor 302 coupled to the memory 301, and an interface 303 coupled to the processor 302.

The interface 303 is configured to communicate with the monitor device, the interface includes the display 303a, is configured to obtain monitor data from the monitor device coupled to the ostomy appliance, and the monitor data includes the sensor data as well as the base plate. Sensor data is obtained from one or more sensors in the monitor device, including one or more of the ostomy data obtained from the electrodes of the base plate and parameter data based on the ostomy data obtained from the electrodes of the base plate. Monitor data, or at least a portion thereof, may be stored in memory 301.

The processor 302 determines the operating state of the base plate based on the sensor data, one or more of the ostomy data, and the parameter data based on the ostomy data, and the first user interface object 402 representing the operating state of the base plate on the display 303a. The first user interface 400 including the above is displayed (see FIG. 12).

Processor 302 is configured to communicate with one or more devices in the ostomy system. One or more devices include a monitor device disclosed herein and an ostomy brace configured to be placed on the user's skin surface or any additional seal. Ostomy equipment includes a base plate. The base plate may include a first adhesive layer with a proximal side. During use, the proximal surface of the first adhesive layer adheres to the user's skin in the area surrounding the stoma and / or additional encapsulation such as encapsulating paste, encapsulating tape, and / or encapsulating ring. The base plate may include one or more electrodes configured to measure the electrical properties of the first adhesive layer. Electrical properties can indicate conductive paths within the first adhesive layer, thus indicating moisture levels, and can indicate the status of the base plate of the ostomy brace.

The interface 303 includes a display 303a and a transmitter / receiver unit 303b including a transmitter and an antenna. The interface 303 is configured to acquire monitor data from the monitor device, for example, to receive or retrieve monitor data from the monitor device. The transceiver unit 303b may be configured to acquire monitor data from one or more devices, for example from a monitor device.

Interface 303 is configured to acquire monitor data from one or more devices. Monitor data may indicate the condition of the ostomy brace, eg, the condition of some layer of the ostomy brace (eg, the first adhesive layer of the base plate) on the proximal side towards the skin surface.

The processor 302 determines the operating state of the base plate based on the sensor data, one or more of the ostomy data, and the parameter data based on the ostomy data, and displays a first user interface object representing the operating state of the base plate on the display 303a. It is configured to display a first user interface that includes. Ancillary devices may be configured to communicate operating conditions to, for example, users and / or other devices via display 303a or transceiver unit 303b.

In the attached device 8, determining the operating state of the base plate based on the sensor data and one or more of the ostomy data and the parameter data based on the ostomy data can be optionally determined by one or more of the sensor data and the ostomy data. And the first user interface object represents the expected remaining mounting time of the base plate, including determining the expected remaining mounting time of the base plate based on parameter data based on ostomy data. Determining the expected remaining mounting time of the base plate includes determining the change in the current expected remaining mounting time of the base plate, and the estimated remaining mounting time of the base plate is the current expected remaining mounting time and the current expected remaining mounting time. Based on changes in. Further, determining the expected remaining mounting time of the base plate includes increasing the current expected remaining mounting time of the base plate as the increasing criterion set is met. At least the first growth criterion in the growth criterion set is optionally based on sensor data. The sensor data optionally includes the humidity data of the humidity sensor in the monitoring device, and the operating state of the base plate is based on the humidity data.

The sensor data optionally includes the temperature data of the temperature sensor in the monitor device, and the operating state of the base plate is based on the temperature data.

Processor 302 determines the current moisture pattern type based on ostomy data and / or parameters based on the ostomy data, and generates an operating state based on the current moisture pattern type and the sensor data of the monitor device. , The operating state of the base plate is configured to be determined based on sensor data and one or more of ostomy data and parameter data based on ostomy data. Determining the current moisture pattern type can be obtained based on ostomy data and / or parameter data (eg, first parameter data and second parameter data), eg resistance to measurements obtained by the electrodes, eg resistance. Obtained based on capacitance and / or inductance measurements, such as timing information.

The processor 302 may be configured to determine the operating state based on the current operating state and, optionally, any past operating state before determining the operating state.

Determining the operating state of the base plate of an ostomy brace may include determining a certain operating state from a set of operating states. In other words, determining an operating state is to select an operating state from a set of predefined operating states based on sensor data and one or more of ostomy data and parameter data based on the ostomy data. May include. A set of predefined operating states may include a plurality of operating states, such as at least two operating states, at least three operating states, at least four operating states, and at least five operating states. The number of operating states can be in the range of 4-20. In one or more exemplary ancillary devices, the number of operating states in a set of predefined operating states is greater than 10, eg, greater than 20, or even greater than 50.

The processor 302 may be configured to display on the display a first user interface that includes a first user interface object that represents the operating state of the base plate.

The processor 302 includes a first user interface object that represents the operating state of the base plate on the display by notifying the user through the interface 303, for example by displaying the notification on the display 303a of the accessory device 8. Can be configured to display the user interface of. The notification may include a first user interface object that represents the operating state. The notification may include a notification indicator that opens an application for the ostomy brace.

FIG. 12 shows an exemplary accessory device 8 displaying the first user interface 400 on the display 303a. The first user interface 400 includes a first user interface object 402 that represents the expected remaining wearing time (3 hours 30 minutes) determined by the processor of the accessory device 8.

FIG. 13 shows an exemplary accessory device 8. The processor of the attached device 8 determines the change of 1 hour in the current expected remaining mounting time of 3 hours and 30 minutes, determines the expected remaining mounting time as the sum of the current forecast and the change, and determines the expected remaining of 4 hours and 30 minutes. The wearing time is obtained, which is represented by the first user interface object 402 of the first user interface 400.

FIG. 14 shows a flow chart of an exemplary method. Method 500 is performed within an ancillary device of the ostomy system, eg, ancillary device 8 of the ostomy system 1, wherein the ancillary device includes an interface configured to communicate with one or more devices of the ostomy system. Including a display, the ostomy system includes a monitor device and / or an ostomy device configured to be placed on the user's skin surface, the ostomy device includes a base plate, and method 500 is to acquire monitor data 502. The monitor data includes the sensor data and one or more of the ostomy data obtained from the electrodes of the base plate and the parameter data based on the ostomy data obtained from the electrodes of the base plate, and the sensor data includes one or more of the ostomy data in the monitor device. To determine the operating state of the base plate based on the acquisition and one or more of the sensor data and the ostomy data and the parameter data based on the ostomy data obtained from the sensor of 504, and the operating state of the base plate on the display. 506, including displaying a first user interface, including a first user interface object representing.

In method 500, determining the operating state of the base plate based on the sensor data and one or more of the ostomy data and the parameter data based on the ostomy data is a parameter based on the sensor data and one or more of the ostomy data and the ostomy data. The first user interface object represents the expected remaining mounting time of the base plate, including determining the expected remaining mounting time of the base plate based on the data 504a.

Optionally, determining the expected remaining mounting time of the base plate 504a includes determining a change in the current expected remaining mounting time of the base plate 504b, and the prediction of the estimated remaining mounting time of the base plate is the current expected remaining mounting time. Based on changes in wearing time and current expected remaining wearing time. Further, determining the expected remaining mounting time of the base plate 504a optionally includes increasing the current expected remaining mounting time of the base plate, eg, depending on the increase criterion set being met 504c.

FIG. 15A shows an exemplary graph 2302 of parameter data as a function of time for a first type of base plate at a first predetermined temperature. The first predetermined temperature of the example shown in FIG. 15A is 32 degrees Celsius. FIG. 15B shows an exemplary graph 2304 of parameter data as a function of time for a first type of base plate at a second predetermined temperature. The second predetermined temperature of the example shown in FIG. 15B is 37 degrees Celsius. The temperature was chosen to closely approximate the human skin temperature.

15A and 15B were obtained by applying a fluid to the stoma opening of the base plate, and the diameter of the stoma opening was 22 mm. The residual humidity of the environment was 50% in both experiments. Parameter data (eg, voltage (mV)) is applied to the first electrode pair, the second electrode pair, and /, respectively, while the fluid is absorbed by the base plate over time and propagates radially outward from the stoma opening. Or it was measured between the third electrode pairs.

Specifically, in FIG. 15A, curve 2306 shows a voltage drop in about 8.3 hours with respect to the first electrode pair as a function of time. Curve 2308 shows a constant voltage with respect to the second pair of electrodes as a function of time. Also, the electrode 2310 exhibits a constant voltage with respect to the third electrode pair as a function of time.

For comparison, in FIG. 15B, curve 2312 shows the voltage drop at about 7.6 hours with respect to the first electrode pair. Curve 2314 shows a constant voltage with respect to the second pair of electrodes as a function of time. Also, the electrode 2316 shows a constant voltage with respect to the third electrode pair as a function of time.

In other words, in this example, the water propagated when the temperature was 37 degrees Celsius about 11% faster than when the temperature was 32 degrees Celsius. This comparison shows that higher temperatures accelerate moisture propagation and adhesion degradation, resulting in shorter base plate mounting time.

Other experiments were performed to measure the propagation velocity of the fluid through the stoma opening of the second type of base plate. Similar to the experiments shown in FIGS. 15A and 15B, the stoma opening had a diameter of 22 mm and an environmental residual humidity of 50%. The second type base plate is different from the first type base plate in that the composition of the first adhesive layer of the first type base plate is different from the composition of the first adhesive layer of the second type base plate. It differs in that.

In this experiment, when the temperature was 32 degrees Celsius, the fluid propagated between the center of the hole and the first pair of electrodes at about 0.15 mm / hour. In contrast, when the temperature was 37 degrees Celsius, the fluid propagated at about 0.2 mm / hour. Therefore, in this experiment as well, it was clarified that for other types of base plates, the mounting time of the second type of base plate becomes shorter due to the acceleration of moisture propagation and adhesive deterioration as the temperature decreases.

In view of the above results, the gradual counting rate can be applied to the operating state of the base plate (eg, mounting time), and the gradual counting rate has a negative effect on the operating state with the base plate as the temperature rises (eg, mounting). The time is reduced) and / or the rate of decrease in counting has a positive effect on the operating state of the base plate as the temperature decreases (eg, the mounting time increases).

In some embodiments, the counting reduction rate can be predetermined. In these embodiments, the predetermined counting reduction rate can be constant. Alternatively, the predetermined counting reduction rate can be iteratively adjusted based on when the first electrode pair, the second electrode pair, and / or the third electrode pair are triggered. In at least some of these embodiments, the predetermined count-decrease rate can be adjusted repeatedly.

The use of terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary" does not imply any particular order and is individual. Included to identify the element. Moreover, the use of terms such as "first", "second", "third" and "fourth", "primary", "secondary", "tertiary" does not indicate any order or importance. Rather, terms such as "first," "second," "third," and "fourth," "primary," "secondary," and "tertiary" are used to distinguish one element from another. Will be done. The terms "first", "second", "third" and "fourth", "primary", "secondary", "tertiary" and the like are used in this specification and elsewhere for labeling purposes. Used only in, and is not intended to indicate any particular spatial or temporal order. Furthermore, the label of the first element does not imply the existence of the second element, and vice versa.

Although specific features have been shown and described, it is understood that there is no intent to limit the invention described in the claims and various without departing from the spirit and scope of the claims. It will be apparent to those skilled in the art that changes and modifications can be made. The present specification and drawings should be viewed in an exemplary sense, not in a limited sense. The invention described in the claims is intended to include all alternatives, modifications and equivalents.

1 Ostmy system 2 Ostmy equipment 4 Base plate 6 Monitor device 8 Attached device 10 Sensor device 12 Network 14 Coupling member 16 Coupling ring 18, 18A, 18B, 18C, 18D Stormer opening 19 Opening center 20 Docking station 22 First connector 24 Docking station user interface 100 Monitor device housing 101 Processor 102 First interface 104 Second interface 106 Memory 108 Monitor device ground terminal 110 Monitor device first terminal 112 Monitor device second terminal 114 Monitor device first Terminal 3 116 Terminal 4 of the monitor device 118 Terminal 5 of the monitor device 120 Coupling 121 Power unit 122 Antenna 124 Radio transmitter / receiver 126 Loud speaker 128 Tactile feedback element 140 Sensor unit 142 Sensor data 144 First sensor 146 Second sensor 200 First adhesive layer 200A Distal surface of the first adhesive layer 200B Proximal surface of the first adhesive layer 202 Second adhesive layer 202A Distal surface of the second adhesive layer 202B Second Proximal surface of adhesive layer 204 Electrode assembly 204A Distal surface of electrode assembly 204B Proximal surface of electrode assembly 206 Peeling liner 206A Distal surface of peeling liner 206B Proximal surface of peeling liner 208 Upper layer 208A Distal surface of upper layer Surface 208B Proximal surface of upper layer 209 Coupling ring 210 Coupling part of first connector 211 First connector 212 Terminal of first connector 213 First intermediate element 213A Distal surface of first intermediate element 213B First Proximal surface of intermediate element 214 Support layer of electrode assembly 214A Distal surface of support layer 214B Proximal surface of support layer 216 Electrode of electrode assembly 217 Electrode connection 218, 219 Masking element 218A Distal surface of masking element 218B Proximal surface of masking element 220, 220A, 220B Electrode configuration 222 Ground electrode 222A Ground connection 222B Ground detection part 222C Ground connector part 224 First electrode 224A First connection part 224B First sensing part 224C First Conductor part 226 2nd electrode 226A 2nd Connection part 226B Second detection part 226C Second conductor part 228 Third electrode 228A Third connection part 228B Third detection part 228C Third conductor part 230 Fourth electrode 230A Fourth connection Part 230B 4th detection part 232 5th electrode 232A 5th connection part 232B 5th detection part 234 1st electrode part of ground electrode 236 2nd electrode part of ground electrode 238 3rd electrode of ground electrode Part 240 Fourth electrode part of ground electrode 242 Ground terminal opening 244 First terminal opening 246 Second terminal opening 248 Third terminal opening 250 Fourth terminal opening 252 Fifth terminal opening 254 Primary sensor point opening of masking element 254A Primary sensor point opening 254B Second primary sensor point opening 256 Secondary sensor point opening of masking element 256A First secondary sensor point opening 256B Second Secondary sensor point opening 258 Third sensor point opening of masking element 258A First tertiary sensor point opening 258B Second tertiary sensor point opening 260 Primary sensor point opening of first adhesive layer 260A First Primary sensor point opening 260B Second primary sensor point opening 262 Secondary sensor point opening of first adhesive layer 262A First secondary sensor point opening 262B Second secondary sensor point opening 264 First 264A 1st tertiary sensor point opening 264B 2nd tertiary sensor point opening 282 ground terminal element 282A ground terminal 284 1st terminal element 284A 1st terminal 286 2nd terminal Element 286A 2nd terminal 288 3rd terminal element 288A 3rd terminal 290 4th terminal element 290A 4th terminal 292 5th terminal element 292A 5th terminal 301 Memory 302 Processor 303 Interface 303a Display 303b Transmitter / receiver Unit 400 1st user interface 402 1st user interface object 500 Method 502 Acquire monitor data 504 Judge operating status 504a Judge remaining mounting time 504b Judge current expected remaining mounting time Change 504c Current expected remaining mounting time of base plate Increased wearing time 506 Display first user interface 2302 First predetermined Graph of parameter data as a function of time at temperature 2304 Graph of parameter data as a function of time at a second predetermined temperature 2306 Voltage drop with respect to a first electrode pair at a first predetermined temperature Curve shown as a function of time 2308 Curve showing a constant voltage for the second electrode pair at the first predetermined temperature as a function of time 2310 Constant voltage for the third electrode pair at the first predetermined temperature Curve shown as a function of time 2312 Curve showing the voltage drop with respect to the first electrode pair at a second predetermined temperature as a function of time 2314 Constant voltage with respect to the second electrode pair at a second predetermined temperature with time Curve shown as a function of 2316 A curve showing a constant voltage for a third pair of electrodes at a second predetermined temperature as a function of time

Claims (15)

Including a monitor device and an ostomy brace, the ostomy brace is an accessory device for an ostomy system that includes a base plate.
With memory
With the processor
An interface coupled to the processor and configured to communicate with the monitor device, including a display, configured to obtain monitor data from the monitor device coupled to the ostomy appliance, said monitor data. Includes sensor data and one or more of the ostomy data acquired from the electrodes of the base plate and parameter data based on the ostomy data acquired from the electrodes of the base plate, the sensor data being one or more in the monitor device. The interface and, which are obtained from the sensor of
Including
The processor
The operating state of the base plate is determined based on the sensor data, one or more of the ostomy data, and parameter data based on the ostomy data.
An accessory device configured to display a first user interface on the display, including a first user interface object representing said operating state of the base plate. Determining the operating state of the base plate based on one or more of the sensor data and the ostomy data and parameter data based on the ostomy data can determine the expected remaining mounting time of the base plate by one or more of the sensor data and the ostomy data. The ancillary device of claim 1, wherein the first user interface object represents the expected remaining mounting time of the base plate, comprising making a determination based on parameter data based on plural and ostomy data. Determining the expected remaining mounting time of the base plate includes determining a change in the current expected remaining mounting time of the base plate, and the expected remaining mounting time of the base plate is the current expected remaining mounting time and the said. The accessory device according to claim 2, based on the change in the current expected remaining wearing time. Any one of claims 2 to 3, wherein determining the expected remaining mounting time of the base plate includes increasing the current expected remaining mounting time of the base plate in response to the fulfillment of the increasing criterion set. Attached device described in. The accessory device according to claim 4, wherein the first increase criterion of the increase criterion set is based on the sensor data. The accessory device according to any one of claims 1 to 5, wherein the sensor data includes humidity data of a humidity sensor in the monitor device, and the operating state of the base plate is based on the humidity data. The accessory device according to any one of claims 1 to 6, wherein the sensor data includes temperature data of a temperature sensor in the monitor device, and the operating state of the base plate is based on the temperature data. The accessory device according to any one of claims 1 to 7, wherein the sensor data includes gyroscope data of a gyroscope in the monitor device, and the operating state of the base plate is based on the gyroscope data. The accessory device according to any one of claims 1 to 8, wherein the sensor data includes magnetometer data of a magnetometer in the monitor device, and the operating state of the base plate is based on the magnetometer data. The accessory device according to any one of claims 1 to 9, wherein the first user interface object is a notification. The accessory device according to any one of claims 1 to 9, wherein the first user interface object is an application start icon, and the first user interface is a home screen. In a method performed within an ancillary device of the ostomy system, the ancillary device comprises an interface configured to communicate with one or more devices of the ostomy system, the interface including a display, said the ostomy system. Includes a monitor device and / or an ostomy device configured to be placed on the user's skin surface, said ostomy device including a base plate.
Acquiring monitor data, the monitor data includes sensor data, one or more ostomy data acquired from the electrodes of the base plate, and parameter data based on the ostomy data obtained from the electrodes of the base plate. Including, the sensor data is obtained from one or more sensors in the monitor device, and the acquisition.
Judging the operating state of the base plate based on the sensor data, one or more of the ostomy data, and parameter data based on the ostomy data.
To display a first user interface on the display, including a first user interface object representing the operating state of the base plate.
How to include. Determining the operating state of the base plate based on one or more of the sensor data and the ostomy data and parameter data based on the ostomy data can determine the expected remaining mounting time of the base plate by one or more of the sensor data and the ostomy data. 12. The method of claim 12, wherein the first user interface object represents the expected remaining mounting time of the base plate, comprising making a determination based on parameter data based on plural and ostomy data. Determining the expected remaining mounting time of the base plate includes determining a change in the current expected remaining mounting time of the base plate, and the expected remaining mounting time of the base plate is the current expected remaining mounting time and the said. 13. The method of claim 13, based on said change in the current expected remaining wearing time. Any one of claims 13-14, wherein determining the expected remaining mounting time of the base plate includes increasing the current expected remaining mounting time of the base plate in response to the fulfillment of the increasing criteria set. The method described in.

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